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Safety Use Of The Iron Oxide

To support the safety of the proposed uses of synthetic iron oxide, we provided information about iron intake expected to result from the proposed new uses of synthetic iron oxide, as well as intake from other sources of iron. There are many dietary sources of iron, including from food ingredients, dietary supplements, and from food that contains naturally occurring iron.

Specifically, we submitted detailed exposure estimates of iron that took into account the following:

1. The proposed uses of synthetic iron oxide as a color additive in soft and hard candy, mints, and chewing gum based on the maximum anticipated use levels.

2. The current use of synthetic iron oxide to color sausage casings.

3. Background iron from conventional food based on the iron content declared on food labels.

4. Iron from dietary supplements.

5. Oral exposure to iron oxides from their use as color additives in lipstick.

These exposure estimates assumed that all of the iron that is present is absorbed in the gastrointestinal tract. we also provided exposure estimates to iron that took into account the bioavailability of iron from all current dietary sources, proposed uses, and lipstick. we compared these intake estimates to the Tolerable Upper Intake Level (UL) for iron established by the Institute of Medicine (IOM) of the National Academies. Based on this and other information, we concluded that the proposed use of synthetic iron oxide to color soft and hard candy, mints, and chewing gum is safe.